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Completed

NCT Number: NCT02172638

Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management

The concept of Fast-trak or Enhanced Recovery After Surgery ( ERAS) represents a new approach to the management of patients undergoing major surgery that re-examine traditional practices, replacing them if necessary with the best evidence based practices, creating a multimodal perioperative care pathway designed to achieve early recovery. In Colorectal Cancer Surgery , as well as in a number of other procedures it has been shown to reduce Hospitalization by more than 30% without increasing the rate complications or readmissions.

However information on the results of Fast-track protocols when applied to Gynecological patients is sparse, being especially notorious the lack of data regarding the efficacy of Fast-track in the management of Advanced Gynecological cancer.

Hypothesis: the application of a Fast-Track protocol in the management of patients with advanced Ovarian Cancer( Stage III, IV and relapses) may improve the postoperatory recovery of these patients allowing for an early discharge and significant cost reduction, when compared with de usual management, without increasing the number readmission or surgery related complications.

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Key information

Conditions

Median Length of Stay Adnexal Diseases Cost Per Patient Rate Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Readmission Rate Surgery Related Complications Rate Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or more
  • Advanced ovarian cancer ( FIGO Stages III-IV, and relapses) tributary to laparotomic surgical management.
  • Patient accepts participation in the study and signs informed consent.

Exclusion criteria

  • ASA IV
  • Active ischemic cardiac condition
  • Advanced cirrhosis ( Child-Pugh B -C).
  • Severe Psychiatric condition ( patient not capable of giving her informed consent properly, not capable or not willing to attend Follow-up visits).

Treatment and study plan

Fast-Track Protocol

Procedure

Other names: Enhanced Recovery After Surgery, ERAS protocol

Usual management

Procedure

Other names: Classical management, Conventional care

Primary outcomes

  1. median length of stay

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Secondary outcomes

  1. Number of readmissions related to postoperative complications.

    Time frame: 28 days after surgery

    To determine if there is an statistically significant difference in the readmission rate related to postoperative complications between the Fast-track and Classical management groups.

  2. Number of surgery related complications

    Time frame: 28 days after surgery.

    To determine if there is an statistically significant difference in surgery related complications rates between the Fast-track and Classical management groups.

    The number and severity will be recorded. as graded in the Clavien-Dindo Classification of Surgical Complications.

  3. Cost per patient

    Time frame: 28 days after surgery

    To determine if the application of a Fast-Track protocol in advanced ovarian cancer patients generates a significant cost per patient reduction when compared with classical management. The total cost for Hospitalization , readmissions and surgery related complications will be assessed according to the Public prices published in : SLT/383/2009, 21th January "Diari Oficial de la Generalitat de Catalunya" Núm. 5325 - 24.2.2009.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Ensayo clínico Comparando Recuperación Postoperatoria Tras Protocolo FAST- TRACK Vs. Manejo Clásico en Cáncer de Ovario Avanzado

Acronym: PROFAST

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 24, 2014
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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